At the 2013 Leipzig Interventional Course (LINC) meeting in Leipzig, Germany, 30-day results from the ESPRIT I trial were presented. The trial is a prospective, single arm, multicenter outside the US trial with enrollment of 35 patients evaluating the Esprit drug-eluting bioresorbable vascular scaffold (BVS) by Abbott. The objective was to evaluate the safety and performance of the Esprit BVS in subjects with symptomatic atherosclerotic disease of the SFA or iliac arteries.
In each patient, one target lesion was treated with a single 6 x 58 mm Esprit BVS, in vessels with diameters between 5.5 mm and 6.5 mm and segment length of less than 50 mm. Inclusion criteria were RB clinical category 1 to 3, single de novo lesion of the SFA or common or external iliac arteries, lesion length ≤50 mm, and vessel diameter from ≥5.5 mm to ≤6.5 mm. At the end of 30 days, no clinical endpoint events or scaffold thrombosis was observed.
Other highlights from the 30-day results of the study include 100% acute procedural success, angiographic and duplex ultrasound results that showed widely patent arteries after the procedure that were sustained to 1 month, no indicators of acute scaffold recoil on angiography, no binary restenosis on duplex ultrasound, substantial improvement in functional status, and a drop in severe claudicants (Rutherford-Becker clinical category 3) from 57% at baseline to 0%.
Vascular Disease Management interviewed Johannes Lammer, MD, professor of radiology at the Medical University of Vienna, Austria, and principal investigator for the ESPRIT I trial about the 30-day results.
Q: Please give a brief overview of the study.
A: The purpose is a first-in-man evaluation of the bioabsorbable, everolimus-eluting vascular scaffold in peripheral arteries. The main focus is on safety; however, there are several substudies, including pharmacokinetics, biodegredation and intravascular ultrasound, 1-year patency, and noninvasive imaging by computed tomography angiography or magnetic resonance angiography).
Q: What advantage could a bioresorbable stent offer over traditional therapies for vessels in the legs?
A: The advantage of a bioresorbable scaffold is that the acute problems of angioplasty, such as dissection and residual stenosis, are treated by a stent, but the long-term disadvantages of stents, such as fracture and restenosis, do not exist after resorption.
Q: Please describe the scope of the ESPRIT I study.
A: The ESPRIT I study is a first-in-man study with 35 patients. Inclusion criteria are intermittent claudication due to external iliac or superficial femoral artery stenoses.
Q: What limitations, if any, have been found so far?
A: So far the 30 day results are analyzed. There have been no severe adverse events such as thrombosis, stenosis, occlusion, need for target lesion revascularization, bypass or amputation.
Q: What results are most remarkable from 30-day information?
A: Most remarkable are the mechanical properties of the Esprit BVS. The poly-L-lactide scaffold is placed by balloon expansion and acts like a self-expandable stent thereafter. The average in-segment stenosis of 80% (including total occlusions in 23%) was reduced to 13% after the procedure. Before treatment, 91.4% had severe-moderate claudication (Rutherford-Becker clinical category 2-3), after treatment 97.0% had no claudication or mild claudication (Rutherford-Becker clinical category 0-1) with an Ankle Brachial Index of 1.0.
Q: What is the current status of the study, and when will more results be available?
A: Currently patients are undergoing 6 month follow-up. The results will be presented following analysis of the data. One-year results for ESPRIT I are anticipated in the first half of 2014.
Johannes Lammer, MD, is professor of radiology at the Medical University of Vienna, Austria. Dr. Lammer reports consultancy to the SSAB meeting and honoraria related to the ESPRIT I trial.